SERVICES
Pharmaceutical
CEMAS carries out a range of GMP and GLP-compliant studies in support of the development or registration of drug substances and formulations for both the human and animal health industry to current ICH and VICH guidelines.
Analytical support, including:
- QC release / Certificates of Analysis
- Raw material analysis
- Storage stability trials to ICH guidelines
- Photostability testing
- Veterinary medicine services to VICH guidelines
- Method development, method transfer and method validation
Specific testing, including:
- Stability-indicating methods
- Active ingredient content
- Related substances / impurities content
- Residual volatile organic compounds determination
- Dissolution, disintegration, hardness and friability testing
- Metal impurities via ICP
- Elemental analysis
- Swab analysis for cleaning verification methods
- Range of physical testing
Storage
Storage Stability Trials to current ICH Guidelines (storage cabinets at 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, and additionally a range of temperature controlled storage at ambient humidity)
Compliance
Read about the CEMAS Quality Assurance Unit
Equipment
Read about the equipment used by CEMAS
CEMAS is an independent, privately-owned, contract research organisation that provides support to the agrochemical, pharmaceutical, veterinary medicine and biocide industries.
